Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring type 2 diabetes, vildagliptin
Eligibility Criteria
Inclusion Criteria: Blood glucose criteria must be met On a stable dose of insulin as defined by the protocol Body mass inde (BMI) in the range 22-45 Exclusion Criteria: Type 1 diabetes Pregnancy or lactation Evidence of serious diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol defined exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c at 24 weeks
Secondary Outcome Measures
Change from baseline in fasting plasma glucose at 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in mean daily insulin dose at 24 weeks
Change from baseline in mean daily number of insulin injections at 24 weeks
Patients with endpoint <7% after 24 weeks
Full Information
NCT ID
NCT00099931
First Posted
December 21, 2004
Last Updated
May 4, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00099931
Brief Title
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Official Title
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
type 2 diabetes, vildagliptin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c at 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in fasting plasma glucose at 24 weeks
Title
Adverse event profile after 24 weeks of treatment
Title
Change from baseline in mean daily insulin dose at 24 weeks
Title
Change from baseline in mean daily number of insulin injections at 24 weeks
Title
Patients with endpoint <7% after 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Blood glucose criteria must be met
On a stable dose of insulin as defined by the protocol
Body mass inde (BMI) in the range 22-45
Exclusion Criteria:
Type 1 diabetes
Pregnancy or lactation
Evidence of serious diabetic complications
Evidence of serious cardiovascular complications
Laboratory value abnormalities as defined by the protocol
Other protocol defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Investigative Sites
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17387446
Citation
Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. doi: 10.1007/s00125-007-0633-0. Epub 2007 Mar 27.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
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